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Brief Title: Multicentre, Dose Finding, Ph II,CP-4055 in Comb. With Sorafenib - Patients With Metastatic Malignant Melanoma
Official Title: A Multicentre, Dose Finding, Phase II Study of CP-4055 in Combination With Sorafenib in Patients With Metastatic Malignant Melanoma
Study ID: NCT00498836
Brief Summary: Patients with metastatic malignant melanoma will receive CP-4055 200 mg/m2/day intravenously (IV) on Day 1-5 every four weeks and sorafenib 400 mg b.i.d. (twice daily) every day until complete response or disease worsening/progressing.
Detailed Description: This is a multicentre clinical study conducted in the USA and in Europe. It is an open label study designed to investigate objective tumor response, the time to progression (TTP) and the duration of tumor response in patients with metastatic malignant melanoma when treated with CP-4055 in combination with sorafenib (Nexavar®). The safety and tolerability of the treatment will also be assessed.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Cancer Therapy and Research Center, Institute for Drug Development, San Antonio, Texas, United States
The Norwegian Radium Hospital, Oslo, , Norway
Lund University Hospital, Lund, , Sweden
Umeå University Hospital, Umeå, , Sweden
Uppsala University Hospital, Uppsala, , Sweden
Name: Svein Dueland, MD
Affiliation: The Norwegian Radium Hospital, Oslo, Norway
Role: PRINCIPAL_INVESTIGATOR